Frequently Asked Questions

These questions are some that we are asked from time to time by our pharmaceutical and catalyst customers. To make this information as useful as possible it is updated on a regular basis. If you have any questions about how to use your machine, spheronization or about making pellets in general please ask us so that we can include it here. You may also like to look at our highly regarded production throughput calculator.

Spheronization and Spheronizers

How can I be sure that the trials and development work that I do will give me comparable results when I need to scale up to production sizes?

With over 50+ years of experience Caleva have proved that our spheronizers are very successful in scale up from laboratory development to full scale pellet production.  

What are the standard processes that I have to consider when trying to develop or manufacture spheroids or pellets?

There are 4 standard processes to consider when creating spheroids.

Wet Granulation - Granules are formed by the addition of a granulation liquid onto a bed of powder under the influence of an impeller. This is typically carried out using a high-shear granulator or a simpler planetary mixer.

Extrusion - The wet granulation is extruded to form cylindrical extrudate (noodles or spaghetti) of a constant diameter (normally 0.5 – 3 mm).

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I have a Caleva Spheronizer machine where can I get spare parts?

You can find contact information from our distributor page or send us an email info@caleva.com.  You may of course call us by telephone +44 (0)1258 471122 or use our chat facility on the website.  

I put the extrudate in the spheronizer but it is not producing spheres after about 10 minutes and I don’t see any changes.

The extruded material is too hard and/or too dry.  The quality of the spheres depends on the quality of the extrudate.  The quality of the extrudate depends on the quality of the formulation.  In general, the reason for having a small spheronizer is to do trial work.  This trial work can be made considerably easier by the use of a Mixer Torque Rheometer.  For more information on formulation development, either contact Caleva or your local distributor.

I put the extrudate in the spheronizer but all the material sticks together.

The extrudate is too wet.  Look again at the formulation.  The quality of the extrudate depends on the quality of the formulation.  In general, the reason to have a small spheronizer is to do trial work.   This trial work can be made considerably easier by the use of a Mixer Torque Rheometer.  For more information on formulation development, either contact Caleva or your local distributor.

A large amount of dust is being produced when I put material in the spheronizer.

The extrudate is too dry.  More binder is needed. The disc speed may be too high.

How can I make smaller (or larger) spheres?

The diameter of the sphere or pellet produced depends principally on the diameter of the extrudate.  In general, smaller diameter spheres are rotated at higher speeds and larger diameter spheres are rotated at slower speeds but this is not the determining factor in the diameter of the spheres.

How long should the extrudate stay in the spheronizer?

This depends on the formulation characteristics.  It could be anything from about 30 seconds to about 10 minutes.  It is dependent on the product and the quality of it.  

How fast should I run the spheronizer disc?

This depends on the formulation and the amount of material in the spheronizer and would be found by experimentation.  A typical rotation speed of about 800 rpm is a good place to start.

Should the spheronizer be running when the extrudate is added or should I add the extrudate and then start the machine?

It makes little difference but aim to be consistent in the method used.

What happens if I add too much or too little product?

The cycle time will be reduced or increased depending on volumes. Too high or low a load can prevent proper spheronization.

Can I pour water in the bowl to wash it?

This is not advisable.  Remove the bowl and clean with a cloth.

How can I remove the disc to clean underneath it?

See the instructions in the operating manual or contact Caleva.

The spheronizer is plugged in and I have pressed the green start button on the front but it will not work. What could it be?

Providing you are sure you have electrical power the first thing you should check is that the emergency stop button is not depressed (you must twist to release it) and that the on/off switch on the rear of the machine is switched on.  Ensure that the drum and chute covers are fitted correctly.  If the problem persists then contact your local distributor or Caleva.

Mini Coater Drier

Can the results generated be used in the scale up of process development?

Background

We are often asked if parameters used for coating materials in the Mini Coater Drier can be used for “scale up” to production. The desire for a process to be scalable is understandable but it is not always feasible or relevant. 

The Mini Coater Drier has the unique ability to coat very small samples sizes and is typically used at a very early stage in the development of new products and new formulations. The following is a story that demonstrates other applications and benefits of the Mini Coater Drier (MCD).

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Terminology

A note about terminology:-

Spheronization, marumerization, pelletization and micropelletization all mean the same thing. The manufacture of products in small spheres (spheroids) for use in pharmaceutical (pharma) and catalyst industries. Within each batch the spheroids are of regular shape and size and are quite dense. The products produced by these processes can be called spheroids, spheres, micro-spheres, pellets, micro-pellets or pharmaceutical or catalyst pellets. All these terms refer to the same thing. The size range is normally from about 0.8 mm to about 1.5 mm in diameter although smaller and larger are possible they are less common. Granulation normally refers to the manufacture of irregularly shaped particles with a large size range included within the batch. Granulated materials are generally less dense.

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Alternative terms and typical spelling variants used for the processes and equipment that Caleva manufacture.

At Caleva we supply our extrusion and spheronization equipment around the world as well as in the UK. We are a British manufacturer. We have customers in Europe, Asia, Middle East, North America, South America and Australasia. We work closely with and support our customers all across the globe.

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An Important Note on Pharmaceutical Equipment Product Quality

It is possible to purchase extruders and spheronizers at a lower price .... but will it cost you more in the longer term?

Process yields (the % of the spheroids produced in any batch that are within the size range required) will never be 100%.

It is possible to achieve yields of greater than 98% if the formulation, the process parameters and the equipment used are optimised. 

 

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Why spheroids or Pellets?

A better therapeutic effect with spheroids?

In many cases the main reason for the use of pellets in the manufacture of products is for its controlled release properties. However there are reasons to believe that pellets or spheroids in any case can offer a superior therapeutic effect even when modified release is not the prime objective. 

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Commonly spheronized pharmaceutical products

What pharmaceutical products or drugs can I make with pellets

View this list of pharmaceutical drugs and medicines that are processed in the form of pellets or spheroids

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